Suppliers and packagers for LEXISCAN

LEXISCAN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161	NDA	Astellas Pharma US, Inc.	0469-6501-89	5 mL in 1 SYRINGE, PLASTIC (0469-6501-89)	2008-04-10
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1448-1	1 SYRINGE, PLASTIC in 1 CARTON (51662-1448-1) / 5 mL in 1 SYRINGE, PLASTIC	2019-12-10

Suppliers for the Pharmaceutical Drug: Lexiscan

Last updated: July 29, 2025

Introduction

Lexiscan (regadenoson) is a pharmaceutical agent predominantly used in nuclear stress testing to evaluate coronary artery disease. As a selective A2A adenosine receptor agonist, Lexiscan induces coronary vasodilation, facilitating the assessment of myocardial perfusion. The drug’s global supply chain is crucial for healthcare providers, pharmaceutical distributors, and research institutions. This comprehensive overview examines Lexiscan’s primary suppliers, manufacturing landscape, regulatory considerations, and market dynamics.

Manufacturing and Key Suppliers of Lexiscan

Lexiscan’s manufacturing is primarily driven by AstraZeneca, a multinational pharmaceutical company. AstraZeneca is the sole developer and marketer of Lexiscan, overseeing its production, regulatory submissions, and global distribution. The drug’s active pharmaceutical ingredient (API), regadenoson, is synthesized under controlled conditions adhering to stringent quality standards, including Good Manufacturing Practices (GMP).

AstraZeneca’s Role and Manufacturing Facilities

AstraZeneca maintains manufacturing facilities in various regions, often outsourced to contract manufacturing organizations (CMOs) to optimize production capacity and comply with regional regulatory standards. These facilities are strategically located across Europe, North America, and Asia to support global distribution networks. AstraZeneca's dominance as the sole producer simplifies supply chain management but also concentrates risk, making their operational stability critical.

Secondary Suppliers and Contract Manufacturers

While AstraZeneca is the dominant producer, the complexities of pharmaceutical manufacturing have led to the proliferation of CMOs involved in API synthesis, formulation, and packaging processes. Key contract manufacturers involved in the production of regadenoson include:

• Lonza Group: A leading CMO specializing in custom synthesis and biologics, potentially serving as an API supplier or intermediary in the manufacturing chain.
• Samsung BioLogics: Known for biologics, Samsung may contribute to certain components or formulation processes.
• WuXi AppTec: Provides contract services for API synthesis and chemical development, possibly involved in early-stage manufacturing.

However, explicit public confirmation of these companies' involvement in Lexiscan’s supply chain remains limited, underscoring the industry’s confidentiality regarding manufacturing partnerships.

Distribution Channels and Regional Suppliers

Once manufactured, Lexiscan is distributed globally through a network of authorized distributors, wholesalers, and direct supply agreements with healthcare institutions. Suppliers typically include:

• McKesson, Cardinal Health, and AmerisourceBergen: The major pharmaceutical distributors in the United States, responsible for distributing Lexiscan nationwide.
• Regional distributors in Europe and Asia: Companies such as Sigma-Tau and regional branches of major distributors facilitate regional supply.

These distributors ensure shelf availability and manage logistics, especially critical for a drug with specific administration requirements.

Regulatory Approvals and Market Access

Detailed understanding of Lexiscan’s supply chain must include compliance with regulatory frameworks such as the FDA (United States), EMA (European Union), and PMDA (Japan). AstraZeneca secures approvals via these authorities, and production facilities are inspected periodically to ensure GMP compliance. Distributors also hold valid licenses to import, store, and distribute Lexiscan.

Market Dynamics and Supply Chain Challenges

• Consolidation Risks: Dependence on a single manufacturer (AstraZeneca) poses risks such as supply disruptions, regulatory changes, or manufacturing issues.
• Regulatory Variability: Different regional requirements may necessitate local manufacturing or approvals, affecting supplier distribution.
• Supply Chain Disruptions: The COVID-19 pandemic underscored vulnerabilities in pharmaceutical supply chains, with temporary shortages affecting Lexiscan availability in some markets.
• Pricing and Reimbursement Pressures: Negotiations with payers influence procurement decisions and supplier margins.

Emerging Trends and Future Outlook

• Potential for Biosimilar and Generic Entry: Currently, Lexiscan remains protected by patent exclusivity, but upcoming patent expirations could attract new manufacturers.
• Supply Chain Diversification: To mitigate risks, AstraZeneca and distributors might incentivize additional manufacturing partnerships.
• Manufacturing Innovations: Advances in synthesis technologies could reduce costs and increase resilience.

Conclusion

AstraZeneca remains the primary supplier of Lexiscan, with manufacturing concentrated within its facilities and trust-based relationships with CMOs. The drug’s distribution network spans global pharmaceutical wholesalers and regional distributors, all operating under strict regulatory oversight. Future supply stability hinges on diversification strategies, manufacturing innovation, and safeguarding against regulatory and geopolitical disruptions.

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Key Takeaways

• AstraZeneca is the exclusive manufacturer of Lexiscan, responsible for API production and global marketing.
• Contract manufacturing organizations support production but are not publicly confirmed, emphasizing the proprietary nature of the supply chain.
• Major distributors such as McKesson and Cardinal Health facilitate regional and national distribution.
• Supply chain resilience depends on regulatory compliance, diversification, and technological innovation.
• Potential patent expirations and market entry by generics could reshape supplier dynamics.

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FAQs

Q1: Who are the main producers of Lexiscan’s active ingredient?
A: AstraZeneca is the primary producer of regadenoson, the active ingredient in Lexiscan, often utilizing contract manufacturing organizations for synthesis.

Q2: Can other companies manufacture Lexiscan?
A: Currently, AstraZeneca holds exclusive rights, but patent expirations could pave the way for generic manufacturers.

Q3: How is Lexiscan distributed globally?
A: It is distributed through major wholesalers such as McKesson, Cardinal Health, and regional distributors, under strict regulatory compliance.

Q4: What are the risks associated with Lexiscan’s supply chain?
A: Risks include manufacturing disruptions, regulatory hurdles, dependence on a single manufacturer, and geopolitical factors.

Q5: Are there any biosimilars or generics of Lexiscan available?
A: As of now, no biosimilars or generics are available; the drug’s patent protection maintains market exclusivity.

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References

[1] AstraZeneca. Lexiscan (regadenoson) prescribing information. Available at: [AstraZeneca Official Website]
[2] U.S. Food and Drug Administration. Lexiscan Approval and Regulatory Data.
[3] International Pharmaceutical Regulators Forum. Supply Chain Standards and Manufacturing Practices.
[4] Industry reports on pharmaceutical manufacturing and distribution networks.